ConMed Corporation: Medical Device Recall in 2014 - (Recall #: Z-1719-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Product Classification:

Class II

Date Initiated: May 8, 2014

Date Posted: June 11, 2014

Recall Number: Z-1719-2014

Event ID: 68193

Reason for Recall:

ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

Status: Terminated

Product Quantity: Domestic - 12,600 units, Foreign - 44,280 units

Code Information:

Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated